Inserter for intrauterine device

ABSTRACT

An inserter for an intrauterine device is disclosed. The inserter is comprised of a leading end and a trailing end with the leading end formed as a tapered section or a section having a smaller cross-sectional area than the trailing end. The leading end is notched and has a hollowed internal area for receiving a part of a device in cooperation with the notch and the exterior of the tapered or smaller section that is adapted to receive in axial alignment the remainder of the device in nested relation with the inserter. The inserter-intrauterine device combination provides an assembly of reduced volume that permits easy movement through the cervical canal into the uterus for effectively positioning the device.

United States Patent [wi Hoff [ Dec. 23, 1975 INSERTER FOR INTRAUTERINEDEVICE [75] Inventor: Seymour Hoff, San Jose, Calif. [73] Assignee: AlzaCorporation, Palo Alto, Calif.

[22] Filed: Jan. 20, 1975 [21] Appl. No.: 542,283

Related US. Application Data [63] Continuation-in-part of Ser. No.308,596, Nov. 21,

1972, Pat. No. 3,880,156.

[52] US. Cl. 128/130 [51] Int. Cl. A61F 5/46 [58] Field of Search[28/127, 130, 260

[56] References Cited I UNTTED STATES PATENTS 2,324,485 7/1943Chamberlain 128/127 3,077,879 2/1963 Knoch 128/130 3,794,025 2/1974Lerner l28/l30 3,820,535 6/1974 Marco 128/130 3,857,391 12/1974 Lerner128/127 Primary Examiner-Lawrence W. Trapp Attorney, Agent, or FirmPaulL. Sabatine; Edward L. Mandell; Thomas E. Ciotti 57 ABSTRACT An inserterfor an intrauterine device is disclosed. The inserter is comprised of aleading end and a trailing end with the leading end formed as a taperedsection or a section having a smaller cross-sectional area than thetrailing end. The leading end is notched and has a hollowed internalarea for receiving a part of a device in cooperation with the notch andthe exterior of the tapered or smaller section that is adapted toreceive in axial alignment the remainder of the device in nestedrelation with the inserter. The inserter-intrauterine device combinationprovides an assembly of reduced volume that permits easy movementthrough the cervical canal into the uterus for effectively positioningthe device.

11 Claims, 13 Drawing Figures US Patent Dec. 23, 1975 Sheet 1 of43,927,666

FIG.2

US. Patent Dec. 23, 1975 Sheet 2 of 4 3,927,666

US. Patent Dec. 23, 1975 Sheet3of4 3,927,666

y (ll FIG. l0

US. Patent Dec.23, 1975 Sheet40f4 3,927,666

INSERTER FOR INTRAUTERINE DEVICE CROSS REFERENCE TO RELATED APPLICATIONSThis application is a continuation-in-part of U.S. Pat. application Ser.No. 308,596, filed Nov. 21, 1972 now U.S. Pat. No. 3,880,156, whichapplication was assigned to the same assignee as this application.

BACKGROUND OF THE INVENTION The present invention relates to a novel anduseful inserter for placing an intrauterine device within a uterus. Morespecifically, the invention relates to an improved inserter which can beeasily loaded with an intrauterine device with little handling andinserted within the uterus for easily positioning an intrauterine devicein the uterus with both a minimum of trauma and risk of perforation ofthe uterine wall.

Inserters for placing an intrauterine device in a uterus are known tothe prior art. Generally, these inserters were of various shapes andthey consisted of two pieces: a tube or cannula and a plunger or rod.While these inserters have enjoyed wide usage, several majordisadvantages were associated with their use. For example, onedisadvantage is that the inserters were hard to load because theyrequired that the intrauterine device be collapsed and completely forcedinto the cannula which is often time-consuming and difficult. Anotherdisadvantage inherent in the two-piece inserters is that they require ahigh degree of manual dexterity to assure that the intrauterine deviceis effectively pushed from the cannula without changing the prese-Iected shape of the device. The major disadvantage associated with theuse of a two-piece inserter is that they do not provide for theautomatic self-release of the device from the inserter in the uterus.That is, with a two-piece inserter, it is always necessary that thedevice be pushed from the inserter with the rod. Frequently, the rod ispushed too far which leads to perforation of the uterine wall.Additionally, these prior art assemblies comprised of an inserter anddevice, have a large volume, and when they are presented to the cervicalcanal and the uterus, there is a resultant unwanted incident of pain andtrauma accompanying their use.

SUMMARY OF THE INVENTION Accordingly, it is an object of the presentinvention to provide an inserter for placing an intrauterine device inthe uterus that overcomes the disadvantages associated with the priorart.

It is a further object of the invention to provide an inserter forplacing an intrauterine contraceptive device in a mammalian uterus whichinserter is easily loaded, is easy to handle, and easy to use forpositioning the intrauterine device in the uterus.

Another object of the invention is to provide an inserter for holding anintrauterine contraceptive device which inserter self-releases thedevice in the uterus as the inserter is withdrawn therefrom.

Yet still another object of the invention is to make available to theart a novel and useful inserter that can be used with safety and with aminimum of risk of perforation of the uterine wall.

Still a further object of the invention is to provide an inserter thatcan be easily manufactured from either a disposable material or from amaterial that lends itself to repeated use.

It is another object of the invention to provide an inserter that can beeasily removed after placing a device in the uterus.

Yet another object of the invention is to provide an inserter that has asmaller volume thereby requiring a space smaller than the cervical 0sand the cervical canal to substantially lessen the incident of pain andtrauma associated with placing within the uterus an intrauterine device.

Still another object of the invention is to provide an inserter having atapered lead section to reduce the dimensions presented to the cervical0s and canal during insertion of an intrauterine device.

These objects, as well as other objects, features and advantages willbecome more readily apparent from the following detailed description,the drawings and the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, which are not drawnto scale, but rather are set forth to illustrate .various embodiments ofthe invention, the figures are as follows:

FIG. 1 is a view illustrating the improved inserter of the invention.

FIG. 2 is an illustration of one type of intrauterine device that can beplaced in a uterus with the inserter of the invention.

FIG. 3 illustrates an intrauterine device nested in a notch located inthe leading end of an inserter.

FIG. 4 illustrates an intrauterinecontraceptive device nested in theinserter.

FIG. 5 shows a side view of an inserter having a tapered lead section.

FIG. 6 depicts the lead end of a tapered inserter with a pair ofnotches.

FIG. 7 is another side view of a tapered inserter with a curved leadsection.

FIG. 8 illustrates the trailing end of an inserter.

FIG. 9 illustrates a tapered inserter with numbers.

FIG. 10 depicts a method of placing an intrauterine contraceptive devicein a uterus illustrating an inserter intrauterine contraceptive devicecombination with the arms of the device moving toward the smaller areaof the inserter as the combination enters the cervical os.

FIG. ll illustrates in combination an inserter and intrauterine devicewith part of the device nested in the inserter and the remainder thereoflinearly received by the smaller end of the inserter.

FIG. 12 is a sketch of the inserter of the invention positioning anintrauterine contraceptive device in a uterus as the inserter iswithdrawn therefrom.

FIG. 13 illustrates in combination a tapered inserter and intrauterinedevice as the combination moves through the cervical os and canal.

In the drawings and specification, like parts in related figures areidentified by like numbers. The terms appearing earlier in thespecification and in the description of the drawings, as well asembodiments thereof, are further described elsewhere in the disclosure.

DETAILED DESCRIPTION OF THE INVENTION Turning now to the drawings indetail, which are examples of the article of manufacture of theinvention and which are not to be construed as limiting, one embodimentof an inserter is indicated in FIG. 1 by the numeral 10. inserter 10 isa tubular member or rod member having a leading end 11 and a trailingend 16. Inserter 10 at leading end 11 has a receiving area 12,

shaped like a notch, a half square, a half rectangle, a half circle, orother geometric configuration suitable for holding and freely releasingan intrauterine device. Inserter 10 at end 11 has an internal hollowedarea 13 continuous with recess area 12 for slidably receiving within theinserter'an intrauterine device not shown in FIG. I. Hollowed area 13 isseen in dashed lines and it can have various embodiments. For example,in an inserter manufactured from a tubular material hollowed area 13 canextend the length of the inserter, as seen in FIG. 1, or in an insertermanufactured from a rod-like material hollowed area 13 internallyextends at least a distance continuous from the recess area, not shownin FIG. 1, sufficient to internally house and easily release anintrauterine device.

Inserter 10 in FIG. 1 is further uniquely characterized as comprised oftwo integrally formed sections with each section having a differentdiameter. That is, inserter l hasa section of larger diameter 14 and asection of smaller diameter 15 that merge to form a single-pieceinserter 10. Larger diameter 14 extends substantially throughout thelength of the inserter from the trailing end 16 to the point where itmerges with the section of smaller diameter 15. Smaller diameter 15 isof a smaller circumference and occupies a lesser amount of space sinceit is designed for closely receiving parts of an intrauterine device,not seen in FIG. 1. This closeness or effective use of space facilitatesthe advance of the device through the cervical 0s and the cervical canalwith positioning in the uterus of the intrauterine device, while at thesame time it minimizes the likelihood of injury or pain which frequentlyoccurs with prior art devices. That is, inserter 10, at area 15, hassmaller dimensions, thereby requiring a smaller space as the insertertravels through the cervical os, the

cervical canal into the uterus.

FIG. 2 illustrates a conventional intrauterine device that can be easilyand efficiently positioned in a uterus with inserter 10 of theinvention. In FIG. 2, there is depicted an intrauterine device 20 shapedlike a T, and it is similar to the T described in US. Pat. No.3,533,406. The T is comprised of a top crossbar having a left and rightmember identified by 21 and 22, with the bar about 2 to cm in length anda depending member or leg 23 of about 2 to 5 cm in length. The inserterof the invention can be used forinserting a T of the solid filament typeor for inserting a T intrauterine device that contains at least oneantifertility agent that is administered from the T. While the T is apresently preferred embodiment for use with inserter 10, it is to beunderstood that inserter can be used with other intrauterine devices forplacing them in a uterus; that is, intrauterine devices shaped like anarrow, the number seven, and devices having a part that can be housed inthe hollowed area and a part that can rest in the notch.

FIG. 3 illustrates another view of inserter 10 of the invention. In FIG.3 there is seen inserter 10, formed of a single, unit piece ofbiologically acceptable material. Inserter 10 is comprised of notch 12holding an intrauterine device 20 comprised of cross members 21 and 22continuous with shaft 23. Shaft 23 is slidably housed in the leading endand hollowed section 13 of inserter 10. Device 20 is positioned in notch12 and the smaller section of inserter 10.

FIG. 4 illustrates an intrauterine device housed in an inserter 10.Inserter 10 is similar to the inserter of FIG. 1 and it has anadditional embodiment illustrated in FIG. 4 of a stop member or collar24. Inserter 10 in FIG. 4 is about 20 to cm long and member 24 is spacedabout 4 to 8 cm from lead end 11. Member 24 aids in preventingunnecessary penetration beyond the cervical canal and this reduces thelikelihood of injury to a warm blooded uterus. In FIG. 4 at leading end11, a section of wall 25 is removed for illustrating device 20 receivedin notch 12. Top crossbars 21 and 22 of device 20 are seen nestedagainst smaller area 15 for decreasing the volume of the inserter 10intrauterine device 20 assembly. Top crossbars 21 and 22 nested againstsmaller area 15 in side-by-side generally linear relation present asmaller volume to the cervical 0s and the cervical canal duringinsertion and positioning of intrauterine device 20. The smaller section15, which uniformly extended along a part of the inserter, is a meansadapted for receiving the intrauterine device has in the embodimentshown a length of about I to 3 cm. Depending member 23 of device 20 isillustrated by dashed lines and it is housed in hollowed area 13 as seenin FIG. 1. Device 20 is freely nested therein, and it is easily,slidably released from inserter 10.

Turning now to FIG. 5, there is seen an inserter 10 comprising a tubularmember having a leading end 11 and a flanged 37 trailing end 16.Inserter 10 at leading end 11 has a pair of notches 12, not shown inFIG. 5, for receiving, holding and freely releasing an intrauterinedevice therefrom. Inserter 10 is hollowed, 13, for receiving withininserter 10 an intrauterine device, not shown in FIG. 5.

Inserter 10 of FIG. 5 is further characterized as comprised of twosections, a tapered section 34 and a nontapered section 35. Taperedsection 34 starts at lead end 11 and extends towards non-tapered section35 and trailing or rear end 16. Non-tapered section 35 is of uniformdiameter and it extends from trailing end 16 towards leading end 11 tothe point where it merges with tapered section 34. Tapered section 34occupies a lesser amount of space than non-tapered section 35 and it isdesigned for closely receiving parts of an intrauterine device, not seenin FIG. 5, in close, intimate contact to inserter 10. This closeness oreffective use of the exterior space facilitates the advance of device 10through the cervical canal with subsequent placement of an intrauterinedevice in the uterus, while simultaneously reducing the possibility ofinjury and pain which frequently occurs with prior art devices.

FIG. 6 illustrates another view of inserter 10 of FIG. 5. In FIG. 6there is seen the top portion of tapered section 34 comprised of a pairof receiving notches 12 leading to hollowed area 13. Notches 12 are inthe wall of tubular member 10 at the terminus of tapered section 34, andthey are in faced relation or laterally positioned, and of sufficientdepth to engage and orient the transverse member of an intrauterinedevice. FIG. 7 illustrates tapered inserter 10 curved at its leadingsection for easier insertion into a uterine cavity. Curved, taperedinserter 10 of FIG. 7 corresponds to the straight, tapered inserter ofFIG. 5 as it too is made of non-toxic, uterine acceptable materials andadapted to present a small inserter to the reproductive area. FIG. 8,taken through 8-8 of FIG. 7 illustrates trailing end 16 comprised of aflanged member 37 and a hollowed area 13. Flanged member 37 isoptionally used to receive a butter-fly plug, not shown, when a plug isinserted into hollowed area 13 to secure a thread, not shown, thattravels through inserter 10 from an intrauterine device in leading end11. FIG. 9 illustrates a tapered inserter with indicia 38, or numbers,used for sounding a uterusfor determining by art known techniques if anintrauterine device is properly positioned therein.

FIGS. 10, ll, 12 and 13 collectively illustrate a device 20 and inserter10 carries device 20 in nested relation to inserter 10. In actualoperation, inserter 10 is first gently moved against the cervical os33that blends and leads into cervical canal 31. Members 21 and 22 ofintrauterine device 20 initially are spread in open T formation andabuts inserter 10. As inserter 10 enters cervical os 33, members 21 and22 move toward smaller area 15 of inserter 10 to eventually position inaxial alignment with inserter 10.

In FIG. 11, inserter 10 slidably carrying intrauterine contraceptivedevice is seen traveling through cervical canal 31 in route to uterus30. In FIG. 11, members 21 and 22 are now positioned in side-by-sidelinear relation with inserter 10. Members 21 and 22 are in proximatecontact with the wall of inserter 10 in smaller area 15 which area 15 isa means adapted for receiving members 21 and 22. This novel design ofthe invention, comprised of the inserter-intrauterine device combinationpresents a smaller volume to the cervical canal and substantiallyreduces the incident of pain and trauma. Members 21 and 22 are held insmaller area 15 by the walls of the cervical canal until the inserterenters uterus 30. In uterine cavity members 21 and 22, free from theinfluence of the cervical wall return to their original T spacedrelation.

In FIG. 12, there is seen inserter 10 positioning an intrauterinecontraceptive device 20 in uterus 30. In this illustration, members 21and 22 are now in their original open spaced T form. In actual insertionof an intrauterine device, inserter 10 is gently moved through uterus 30until intrauterine device 20 contacts fundus uteri 32. Then, inserter 10is easily withdrawn from uterus 30, while simultaneously slidablyself-releasing and positioning intrauterine device 20 in uterus 30.Inserter 10 is finally, totally withdrawn from the host.

In FIG. 13, there is seen a curved and tapered inserter 10 carryingintrauterine device 20 through cervical canal 31 to uterus 30. In FIG.13, members 21 and 22 are positioned in side-by-side mated relation withthe exterior, tapered section of inserter 10. Members 21 and 22 are inclose contact with the wall of inserter 10 at its tapered section whichis a means adapted for receiving 21 and 22. The novel, curved andtapered inserter preferably has a curved and tapered sectioncorresponding to the female, mammalian reproductive system includingmultiparous, primiparous and nulliparous uteri. The combinationinserter-intrauterine device presents a diminished volume to the systemto reduce the incident of pain and trauma. Members 21 and 22 are held intapered section 34 by the walls of cervical canal 31 until inserter l0enters uterus 30. In uterine cavity 30, members 21 and 22 are freed fromthe influence of the cervical wall and they return to their original Tshaped relation. Inserter 10 is withdrawn as described in FIG. 12.

Inserter 10 of the invention can be manufactured from any suitablematerial, and the material can be of naturally occurring or syntheticorigin. Exemplary macan be made by techniques standard in the art suchas parison forming, extrusion, casting and the like. In-

serter 10 -is about 20 to 50 cm longwith the larger sectionhaving adiameter of about4 to 8mm, and the 5 smaller and tapered section havinga diameter of 2 to 3.5 mm, with the length of the smaller or taperedsection about 12 to 20 mm. Of course these dimensions are representativeof presently preferred inserters, and other inserters of larger orsmaller dimensions in like proportions and like structure are within thescope of the invention.

It will be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained and,since certain changes may be made in carrying out the above method andin the article set forth without departing from the scope of theinvention, it is intended that all matter contained in the abovedescription or shown in the accompanying figures shall be interpreted asillustrative and not in a limiting sense.

I'claim:

1. An inserter for an intrauterine device comprising a transverse memberand a leg member depending therefrom, the inserter comprising:

a. an elongated tapered tubular member having a leading section and atrailing section distant from the leading section;

b. a pair of notches in the terminus of the tubular member at itsleading section, said notches adapted to orient and engage thetransverse member of the device;

c. a hollowed area extended within the tubular member of dimension suchthat the leg portion of the device can be introduced and positionedtherein; and

d. wherein the taper extends along the leading section of the member toexteriorly form a surface adapted to mate with the transverse member ofthe device when in collapsed configuration during the insertion of thedevice within the cervical canal and when the device is housed withinthe inserter.

2. An inserter according to claim 1 wherein the inserter has a stop onthe member for limiting the depth of uterine penetration.

3. An inserter according to claim 1 wherein the inserter is curved alongthe leading tapered section.

4. An inserter according to claim 1 wherein the inserter is flanged atthe trailing section.

5. An inserter according to claim 1 wherein the inserter has indicia onthe trailing section thereof.

6. An inserter according to claim 1 wherein the inserter has indicia onits leading section thereof.

7. An inserter for an intrauterine device and an intrauterine devicecomprising in combination:

a. a tubular member having a leading section and a trailing section andmade from a biologically inert acceptable material;

b. a pair of notches laterally positioned in the tubular member at theterminus of the leading section as a means for positioning and housing apart of the device;

c. a hollowed area in the tubular member extended from the terminus ofthe leading section for internally receiving in cooperation with thenotches a part of the device;

d. a tapered section extended from the terminus of the leading sectionfor exteriorly receiving in cooperation with the notches and thehollowed area a 7 8 part of the device, and wherein the inserter houses;the inserter. e. a device having a transverse member and a leg 9. Aninserter according to claim 7 wherein the demember depending therefromwith the leg member vice is substantially in the shape of a T. in thehollowed area and the transverse member in 10. An inserter according toclaim 7 wherein the the notches. taper increases in diameter towards thetrailing end. 8. An inserter according to claim 7 wherein the trans- 11.An inserter according to claim 7 wherein the verse member is in thenotches and downwardly positaper is curved.

tioned in nested relation along the tapered section of

1. An inserter for an intrauterine device comprising a transverse memberand a leg member depending therefrom, the iNserter comprising: a. anelongated tapered tubular member having a leading section and a trailingsection distant from the leading section; b. a pair of notches in theterminus of the tubular member at its leading section, said notchesadapted to orient and engage the transverse member of the device; c. ahollowed area extended within the tubular member of dimension such thatthe leg portion of the device can be introduced and positioned therein;and d. wherein the taper extends along the leading section of the memberto exteriorly form a surface adapted to mate with the transverse memberof the device when in collapsed configuration during the insertion ofthe device within the cervical canal and when the device is housedwithin the inserter.
 2. An inserter according to claim 1 wherein theinserter has a stop on the member for limiting the depth of uterinepenetration.
 3. An inserter according to claim 1 wherein the inserter iscurved along the leading tapered section.
 4. An inserter according toclaim 1 wherein the inserter is flanged at the trailing section.
 5. Aninserter according to claim 1 wherein the inserter has indicia on thetrailing section thereof.
 6. An inserter according to claim 1 whereinthe inserter has indicia on its leading section thereof.
 7. An inserterfor an intrauterine device and an intrauterine device comprising incombination: a. a tubular member having a leading section and a trailingsection and made from a biologically inert acceptable material; b. apair of notches laterally positioned in the tubular member at theterminus of the leading section as a means for positioning and housing apart of the device; c. a hollowed area in the tubular member extendedfrom the terminus of the leading section for internally receiving incooperation with the notches a part of the device; d. a tapered sectionextended from the terminus of the leading section for exteriorlyreceiving in cooperation with the notches and the hollowed area a partof the device, and wherein the inserter houses; e. a device having atransverse member and a leg member depending therefrom with the legmember in the hollowed area and the transverse member in the notches. 8.An inserter according to claim 7 wherein the transverse member is in thenotches and downwardly positioned in nested relation along the taperedsection of the inserter.
 9. An inserter according to claim 7 wherein thedevice is substantially in the shape of a T.
 10. An inserter accordingto claim 7 wherein the taper increases in diameter towards the trailingend.
 11. An inserter according to claim 7 wherein the taper is curved.